A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

Phase 1 Completed 15 enrolled Hoffmann-La Roche

Non-randomizedSingle-groupOpen-labelOther

Summary

This study was a non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female volunteers using itraconazole as a CYP3A inhibitor. The study was conducted at 1 site in the Netherlands.

Timeline

Start: 2018-07-10
Primary completion: 2018-11-09
Completion: 2018-11-09

Publications

Derks MGM, Wandel C, Young A, Bolt SK, Meyenberg C. Open-Label Assessment of the Effects of Itraconazole and Rifampicin on Balovaptan Pharmacokinetics in Healthy Volunteers. Adv Ther. 2020 Nov;37(11):4720-4729. doi: 10.1007/s12325-020-01491-y. Epub 2020 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Balovaptan	Small molecule	5 mg	Oral
Subject	Itraconazole	Small molecule	200 mg	—

Indications

No indication recorded.